Biochemistry Analyzers in Indiana

Roche Diagnostics is a global leader in in vitro diagnostic (IVD) instruments, assays, and laboratory systems for clinical chemistry, molecular diagnostics, pathology, and specialty testing. The company manufactures high-volume automated analyzer platforms including the cobas® c 703 for clinical chemistry (2,000 tests/hour), cobas® 5800 system for consolidated automation and integration, and Digital LightCycler® System for digital PCR applications. Product offerings span core lab chemistry, hematology, immunochemistry, mass spectrometry solutions (including Ionify® steroid assays), tissue diagnostics with ready-to-use oncology assays, and blood-based biomarker testing (e.g., pTau181 for Alzheimer's-related amyloid pathology). The organization serves laboratory professionals, clinicians, researchers, and patients across multiple laboratory settings. Roche maintains FDA clearances and 510(k) approvals for its analytical systems and assays, with CLIA moderate-complexity categorization for specialized tests. The company provides comprehensive support including eLabDoc document library access (800,000+ documents), e-learning platforms, PACE/CEU accredited training, and clinical education resources. Manufacturing and regulatory operations are supported from US facilities including Indianapolis headquarters.

Infrared Laboratory Systems (ILS) manufactures Synermed® brand clinical chemistry reagents designed for automated laboratory analyzers. The company specializes in eliminating common interferences in routine chemistries—hemolysis, icterus, and turbidity—through classical reactions adapted for near-infrared spectrum analysis, where interferents are transparent. ILS reagents are supplied in liquid form, eliminating prep time and enabling on-board stability with simplified reagent management and reduced waste. The technology has undergone five-year worldwide validation across routine tests on commonly-used analyzers. Product portfolio includes chemistry reagents for kinetic creatinine, latent turbidity detection, and infrared-accuracy assays. ILS markets to clinical laboratories seeking to reduce specimen rejection rates, repeat testing, and operational costs while improving analytical accuracy and productivity. The company holds FDA cGMP compliance, ISO 13485 certification, and accreditation as a Notified Body under the Medical Devices Directive.